Transmission to Competent Authorities BfArM / BVL / PEI of quality defects / batch recalls
Section (§) 68 of the German Medicines Act (Arzneimittelgesetz / AMG) obliges the competent authorities to communicate to the authorities of other EU Member States any information necessary to monitor compliance with the drug-related regulations in force in these Member States. This may also be applicable to authorities of other states, especially those of the signatory states to the European Economic Area. The European Commission has adopted a guideline concerning the mutual notification in case of quality problems in human or veterinary medicinal products (ENTR/6266/00) which came into force on May 1st, 2000: Procedures related to Rapid Alerts
In order to forward this information to the Member States concerned, a common one-page form has been developed that takes up all the relevant information. This form is also used to inform other states where a Mutual Recognition Agreement exists (at present USA and Canada).
It is the duty of BfArM / BVL / PEI to forward information received from the competent authorities of the "Federal States" ("Länderbehörden") to the other States mentioned above. For transmission of these data from the competent "Länderbehörden" to BfArM / BVL / PEI, a national form has been developed which is similar to the above mentioned one.
Hints for using the form:
The RTF Form can be filled directly at the PC: 
Meldebogen zur Übermittlung von Qualitätsproblemen, Chargenrückrufen und Fälschungen (Rapid Alert System) (file size: 38 KB).
To facilitate the above mentioned task, it is preferred that the form be filled by PC using English. Transmission to the competent authority via email is regarded as helpful. However, a coded communication with the Pharmacovigilance Division of the BfArM (pharmacovigilance@bfarm.de) is not possible at present.
The pharmaceutical company is free to use this form for transmission of quality defects / batch recalls to the competent authorities.